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Patients treated with osimertinib after disease recurrence have a high incidence of severe adverse events. Osimertinib has been approved as adjuvant therapy in various countries following a positive result of superior disease-free survival DFS in the osimertinib arm with a hazard ratio of 0.
Furthermore, the planned final analysis of overall survival OS has shown a better survival in osimertinib arm with a hazard ratio of 0. Nevertheless, there is still an ongoing debate whether adjuvant osimertinib after surgical resection or starting osimertinib at disease recurrence is the best option. In recent trials, including advanced non-small cell lung cancer, the study endpoints were mainly progression-free survival PFS , or DFS for peri-operative adjuvant studies, because a meta-analysis showed that PFS could be a surrogate for OS 3.
However, the meta-analysis was based on results obtained with cytotoxic drugs, not tyrosine kinase inhibitors TKI. To answer this question, we curated a case series at our institution in which we documented patterns of recurrence and efficacy and safety of osimertinib after disease recurrence. Consecutive patients who received osimertinib as first-line therapy after surgery at the Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine between September and January were included.
Those who underwent surgery without curative intent were excluded because we did not want to include patients with macroscopic disease i. The pathological stage was defined based on the 8 th edition of the American Joint Committee on Cancer lung cancer staging system and the histological classification 12 was determined based on the World Health Organization Classification of Tumors of the Lung, Pleura, Thymus and Heart The efficacy and adverse events were collected from medical records on February 20 th , We chose the duration of osimertinib treatment DoT as an endpoint for efficacy, because disease recurrence in most patients was revealed by follow-up computed tomography CT or magnetic resonance imaging MRI , they had no measurable disease.